1. Executing Rare Disease Studies

    48:35

    from Medpace CRO / Added

    14 Plays / / 0 Comments

    Presenter: Derenda Nichols - Director Clinical Operations, Medpace Presentation 3 of 3 in Medpace Discovery Series - Rare Disease - Connecting the Dots Planning and executing a study for a Rare Disease is challenging. Major issues exist involving protocol design, patient recruitment and retention, and global regulatory design. •Operational efficiencies utilizing experienced, cross functional teams •Design and maintenance of patient registries for maximum efficiency

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    • Real-World Evidence in Rare Diseases

      34:36

      from Medpace CRO / Added

      16 Plays / / 0 Comments

      Presenter: Alexander Artyomenko MD, PhD - Director Clinical Operations, Medpace Presentation 2 of 3 in Medpace Discovery Series - Rare Disease - Connecting the Dots Planning and executing a study for a Rare Disease is challenging. Major issues exist involving protocol design, patient recruitment and retention, and global regulatory design. This presentation will demonstrate using real-world evidence to successfully execute your rare disease trial and touch on how to best utilize your data.

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      • Discovery Series: Introduction to Rare Disease: Definition, Examples and Clinical Trial Design

        39:31

        from Medpace CRO / Added

        21 Plays / / 0 Comments

        Presenter: Pirouz Shamszad, MD - Medical Director, Medpace Presentation 1 of 3 in Medpace Discovery Series - Rare Disease - Connecting the Dots Key takeaways from this presentation are: Planning and executing a study for a Rare Disease is challenging. Major issues exist involving protocol design, patient recruitment and retention, and global regulatory design. •Best practices to accelerate these novel compounds to commercialization given difficult rare disease and orphan drug studies •Special pediatric population issues with Rare Disease studies •Clinical Trial Design Considerations

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        • Registry Planning and Implementation: An Operational Perspective

          34:06

          from Medpace CRO / Added

          50 Plays / / 0 Comments

          Each Registry is unique. Success stories are based on well established best practices. This session will address factors that contribute to successful Registries including: • Clearly establishing study objectives (agreed by all stakeholders) • Protocol design and easy, user-friendly data collection tools • Monitoring tailored to the study • An appropriate, study-specific safety event detection and processing system • Ease of access to study data when questions are raised

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          • Medical Device Workshop - Trends in Clinical Trials

            01:03:49

            from Medpace CRO / Added

            50 Plays / / 0 Comments

            Trends in European Clinical Trials Are you considering conducting a medical device trial in Europe? This session focuses on current and best practices in conducting global trials to obtain various regulatory approvals including: •Literature review vs. prospective data needs for CE Marking •Pros and cons of using EU to support US approval •EU site seletion considerations: country requirements and timelines •Considerations for post-market trials •Registries vs. Trials •Vigilance and safety reporting

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            • Collaborating on Documents in the Cloud - 21st Century Clinical Trials Webinar

              52:39

              from Montrium / Added

              39 Plays / / 0 Comments

              In the Life Sciences industry, information is the source of innovation. Vast varieties of content and information sources feed the development pipeline. The ability to create, share, navigate, find and protect essential information is critical to research and development groups, clinicians, regulatory agencies, marketing teams, and those who benefit the most — customers. Drug development requires information-intensive work. It behooves Pharmaceutical or Biotechnology companies to establish strong content management systems and processes throughout the drug development cycle. From the scientists leading the drug discovery process to the marketing specialists writing a new drug’s labeling, all contributors need to document their activities for a variety of reasons. More importantly, they need the ability to create, manage, share, and collaborate on key information safely. Any delay caused by poor content management could affect overall time to market — especially critical in this fast-changing, regulatory environment with constant pressure to improve quality, safety, and global access.

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              • Why Should You Consider Participating in a Clinical Trial?

                04:29

                from Patient Power / Added

                8 Plays / / 0 Comments

                Experts are encouraging lymphoma patients to participate in clinical trials. With big changes happening and more coming, they feel it may give patients access to 'tomorrow's medicines today'.

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                • A Day In the Life of Wingspan eTMF

                  07:34

                  from Wingspan / Added

                  170 Plays / / 0 Comments

                  Experience Wingspan eTMF as it is used every day. See how a document flows between multiple users with ease. Follow a document from review to rework to QC and back to the study owner for final review. For more information about Wingspan eTMF, visit http://www.mywingspan.com

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                  • Fabian Sandoval Podcast

                    08:30

                    from DrugDev / Added

                    98 Plays / / 0 Comments

                    In this inspiring interview, Dr Fabian Sandoval, CEO, M.D. & Medical Director of Emerson Clinical Research Institute talks about why he believes physicians should do clinical trials.

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                    • CTTI-Hosted Webinar: Translating Quality by Design Principles into Practice

                      01:00:36

                      from CTTI / Added

                      250 Plays / / 0 Comments

                      QbD emphasizes building quality into a process from the beginning. Applied to clinical development, this approach prospectively examines the objectives of a trial and defines factors (key data and trial processes such as randomization) critical to meeting these objectives. This webinar is the first in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials. Coleen Glessner of Pfizer speaks to the Pfizer experience with QbD, followed by Marta Fields of Seattle Genetics who then speaks to the Seattle Genetics experience.

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